The pharmaceutical regulatory process. (©2008)

• Record Type: Book
• Further Information: Note: Edited by Ira R. Berry, Robert P. Martin.
• Other Names: Berry, Ira R, 1942-; Martin, Robert P (Robert Paul)
• Contents: Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug-approval process : before and after 1962 / Michael P. Peskoe -- Generic drug approval process : Hatch-Waxman Update / Marc S. Gross [and others] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum [and others] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson. Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England -- Active pharmaceutical ingredients / Max S. Lazar -- Obtaining approval of New Drug Applications and Abbreviated New Drug Applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- Obtaining approval of a generic drug : pre- 1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead. Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (x, 469 pages), illustrations
• Subjects: 344.7304/233; Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; Legislation, Drug; Guideline Adherence -- legislation & jurisprudence; Pharmaceutical Preparations -- standards; LAW -- Administrative Law & Regulatory Practice; Drugs -- Law and legislation; Pharmacy -- Law and legislation; United States; United States; Electronic books
• Languages: English
• ISBNs: 9781420070439; 1420070436
• Related ISBNs: 1420070428; 9781420070422
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.